The effectiveness of harpagophytum procumbens cream in the relief of osteoarthritic pain of the knee
| ISRCTN | ISRCTN13351989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13351989 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/01/2016
- Registration date
- 09/02/2016
- Last edited
- 09/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Harpagophytum Procumbens (commonly known as devil’s claw) is a plant that originates from southern Africa. It’s roots are used to reduce pain and fever. The chemicals thought to be responsible for the plants pain killing properties are Harpagoside, Harpagide and Procumbide. This study is testing the pain relieving properties of a cream containing Harpagophytum Procumbens in people suffering from knee pain caused by osteoarthritis.
Who can participate?
Adults suffering from osteoarthritis of the knee.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given a harpagophytum containing cream to apply to their knee. Those in group 2 are given a placebo cream that looks and feels like the harpagophytum containing cream to apply to their knee. All participants assess for themselves the amount of pain they are feeling before and after they have put on the cream.
What are the possible benefits and risks of participating?
There are no risks to participating in this study as the ingredients of the cream are absolutely free of any possible adverse effects.
Where is the study run from?
A number of orthopedic private practices in Thessaloniki and Volos (Greece)
When is the study starting and how long is it expected to run for?
February 2016 to August 2016
Who is funding the study?
Synapse Hellenic Pharmaceuticals & Services
Who is the main contact?
Dr Eleftherios Teperikidis
Contact information
Scientific
Egnatias 117
Thessaloniki
54635
Greece
Study information
| Study design | Double blind, placebo controlled, randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effectiveness of harpagophytum procumbens cream in the relief of osteoarthritic pain of the knee: a double blind, placebo controlled, randomised interventional study |
| Study acronym | HARPAIN TRIAL |
| Study hypothesis | The hypothesis of the study is that harpagophytum Procumbens cream is better than placebo in the relief of osteoarthritic knee pain. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Osteoarthritis of the knee |
| Intervention | Patients who meet the radiographic inclusion criteria will be asked to initially evaluate the level of their pain in the knee on a Visual Analogue Scale (0 – 10). Based on the V.A.S scale result and the level of osteoarthritis it is decided by the researcher whether the inclusion criteria are met. All patients will be asked to sign a patient release form before participating in the trial. Patients will then be randomly assigned to either treatment or placebo group. In the treatment group, 3 mL of a harpagophytum containing cream will be applied on the affected knee. The placebo group will receive 3 mL of a cream that has been designed to have the same color, smell and texture as the active cream. Ten minutes after the application of the cream, patients will be asked to evaluate the level of the pain that they feel on a Visual Analogue Scale (0 – 10), as well as if they experience any adverse effect (skin reaction etc.). Through the ten minute waiting period, the researcher will complete the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), an established and accredited questionnaire used in high quality clinical trials, evaluating the problems caused by Osteoarthritis in patient’s every day life. At the end of the study all researchers will fill out a questionnaire regarding the execution of the trial as per the instructions given. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | Harpagophytum procumbens |
| Primary outcome measure | Patient improvement on pain as evaluated by a Visual Analogue Scale (0-10) ten minutes after application of the cream. |
| Secondary outcome measures | N/A |
| Overall study start date | 01/02/2016 |
| Overall study end date | 01/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 1. Osteoarthritis Stage (Kellgren & Lawrence Scale) 2 - 3 2. Patient’s Knee - Pain Self Evaluation (VAS 0 - 10) 4, 5, 6, 7 |
| Participant exclusion criteria | 1. Osteoarthritis Stage (Kellgren & Lawrence Scale) 0, 1, 4 2. Patient’s Knee- Pain Self Evaluation (VAS 0 - 10) 0 – 3 , 8 - 10 3. Use of analgesic or anti-inflammatory medications, topical or oral on the day of the study |
| Recruitment start date | 01/02/2016 |
| Recruitment end date | 01/08/2016 |
Locations
Countries of recruitment
- Greece
Study participating centre
54635
Greece
Sponsor information
Industry
Egnatias 117
Thessaloniki
54635
Greece
"ROR" |
https://ror.org/01vx59p26 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
